Vogt Koyanagi Harada DiseasePhase 2/3NCT05031143
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
A Phase 2/3 study testing Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease in people with Vogt Koyanagi Harada Disease, run by Benha University at 1 site in Egypt.
Trial summary
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection Read more about this study
- Who is it for?
- Ages 47 to 52 years
- Conditions the study is for
- Vogt Koyanagi Harada Disease
- What is being tested?
- Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 24 Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.
Who cannot join
- recent intraocular surgery.
- patients refuse to participate in the study.
- media opacity and other causes of serous retinal detachment than VKH.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT
Banhā, Qualiobeya, 13511
About this study
Official title: Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection
Read the detailed description
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which was detectable for more than 3 months with limited exposure in the anterior segment. Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated in this study. The aim of this study was to assess the efficacy of suprachoroidal Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT) by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic, Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.
- Conditions
- Vogt Koyanagi Harada Disease
- Being tested
- Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
- Keywords
- Vogt-koyanagi Harada, Suprachoroidal injection
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH diseaseDrug
Also called SCTA for Exudative RD in VKH disease
Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease
| Study group | Role | What they receive |
|---|---|---|
| SCTA injection (n=6 eyes) | Active comparator | Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months. Receives: Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease |
| Non-injected eyes (Standard Treatment) (n=6 eyes) | No intervention | Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (LogMAR units)
Changes in vision from baseline upto 6 months follow up
Measured: 6 months after injection
Secondary outcomes (1)
Central Foveal Thickness measured by Optical Coherence Tomography
Changes in CFT during 6 months after injection
Measured: Upto 6 months after SCTA injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Apr 2020
- Primary completion20 Feb 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vogt Koyanagi Harada DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed Abdelshafy, MD, Principal investigator, Benha University, faculty of medicineMarwa Abdelshafy, MD, Study director, Benha University, faculty of medicineMohamed Anany, MD, Study chair, Benha University, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031143
- Sponsor's protocol ID
- FDASU-RECD-1234441
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease
- ClinicalTrials.gov ID
- NCT05031143
- Acronym / sponsor ID
- FDASU-RECD-1234441
- Conditions
- Vogt Koyanagi Harada Disease
- Keywords
- Vogt-koyanagi Harada, Suprachoroidal injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection
Detailed description
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which was detectable for more than 3 months with limited exposure in the anterior segment. Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated in this study. The aim of this study was to assess the efficacy of suprachoroidal Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT) by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic, Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTA injection (n=6 eyes) | Active comparator | Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH diseaseSuprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months. |
| Non-injected eyes (Standard Treatment) (n=6 eyes) | No intervention | –Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months |
Who may qualify
- Ages
- 47 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.
Key exclusion criteria (3 listed)
- recent intraocular surgery.
- patients refuse to participate in the study.
- media opacity and other causes of serous retinal detachment than VKH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH diseaseAlso: SCTA for Exudative RD in VKH diseaseSuprachoroidal steroid injection for management of serous retinal detachment in VKH disease | Drug | SCTA injection (n=6 eyes) |
Primary outcome
Best Corrected Visual Acuity (LogMAR units)
Time frame: 6 months after injection
Changes in vision from baseline upto 6 months follow up
1 secondary outcome
Central Foveal Thickness measured by Optical Coherence Tomography
Time frame: Upto 6 months after SCTA injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Vogt Koyanagi Harada Disease
Recruiting
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Vogt Koyanagi Harada Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abdelshafy, MD principal investigator
Benha University, faculty of medicine
Marwa Abdelshafy, MD study director
Benha University, faculty of medicine
Mohamed Anany, MD study chair
Benha University, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease in people with Vogt Koyanagi Harada Disease, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (LogMAR units) (time frame: 6 months after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.